FDA 510(k)

RM STAR EX with RMS Needle

Número K: K243097 · 2024-12-26

Data da decisão2024-12-26

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RM STAR EX with RMS Needle is the device name listed in this FDA 510(k) record. The listed applicant is Bomtech Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-12-26 under 510(k) number K243097. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RM STAR EX with RMS Needle?

RM STAR EX with RMS Needle is a medical device that received FDA 510(k) clearance on 2024-12-26. The listed applicant is Bomtech Electronics Co., Ltd.. The 510(k) number is K243097.

When did RM STAR EX with RMS Needle receive FDA 510(k) clearance?

RM STAR EX with RMS Needle received FDA 510(k) clearance on 2024-12-26, under 510(k) number K243097.

Who is the listed applicant for RM STAR EX with RMS Needle?

The FDA 510(k) record lists Bomtech Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RM STAR EX with RMS Needle?

The FDA product code for RM STAR EX with RMS Needle is GEI.

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Outros registros que listam Bomtech Electronics Co., Ltd. como candidato(a)

K243143E-PEN (E-PEN)

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